A Phase 3 Study of Ersodetug in Patients With Tumor-Associated Hyperinsulinism

Eligibility Criteria

• * The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI which must include an oncologist
• * Male or female participants of ≥18 years of age who provide written informed consent
• * Participants with a clinical diagnosis and laboratory confirmation of ICT or NICT, with associated hypoglycemia that is considered refractory to surgery and to usual SOC anti-hypoglycemia therapies, per investigator judgement.
• * Experiencing an average of ≥ 3 hypoglycemia events per week that meet Level 2 criteria and/or Level 3 criteria during the two weeks before randomization
• * Participants who have not previously received tumor-directed therapy (including at least one course/trial of systemic tumor-directed therapy, as appropriate) but are considered appropriate for tumor-directed therapies by the investigator and/or a multi-disciplinary oncology care team.
• * Initiation of, or changes to tumor directed therapies within 8 weeks prior to initiation of study drug, or expected initiation or significant changes to these therapies over the course of the pivotal treatment period
• * Initiation of, or significant changes to, SOC medical (e.g. diazoxide, SSAs, continuous glucagon, mTOR-Inhibitors, etc.) or supplemental enteral treatments (e.g. continuous tube feeds) used for the chronic management of hypoglycemia within 4 weeks of screening (per investigator's discretion), or expected changes to SOC medical therapies over the course of the pivotal treatment period.
• * Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator.